"Valuable" breast care tool gets FDA OK

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A ferramenta “valiosa” do cuidado do peito começa a APROVAÇÃO do FDA

por Diana Bradley, Staff Writer | October 19, 2011
Hologic Inc.’s Trident
specimen radiography system (Credit: Hologic )
Hologic Inc.'s new state-of-the-art Trident specimen radiography system, which verifies breast biopsy samples through improved image quality and workflow, was cleared by the Food and Drug Administration on Oct. 18.

The Bedford, Mass.-based company's mobile system addresses various market needs, noted Dr. Gary M. Levine, director of breast imaging at Hoag Breast Care in Newport Beach, Calif. -- one of the radiologists who evaluated the system -- in a statement. With Hologic's proprietary direct digital detector technology, the system aims to reduce procedure steps and increase accuracy.

"Trident is a valuable tool in helping to improve the delivery of breast care for women," Levine said.

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Designed for use in the operating room and biopsy suites, the self-contained system enables physicians to perform verification within close proximity of the procedure, eliminating the need for samples to be taken elsewhere for X-ray imaging. The Trident system has a selenium-based detector, with a 12 cm x 14 cm active imaging area.

"Our goal is to provide leading-edge technologies that improve the diagnostic precision of procedures and create a better experience for patients and their health care providers," Peter Soltani, senior vice president and general manager of breast health at Hologic, said in a statement. "The Trident system more than meets these expectations and is an example of our commitment to excellence in breast cancer detection and diagnosis."

The system offers one-button Automatic Exposure Control, along with one-button export to PACS or to the Hologic SecurView diagnostic workstation; extensive training or experience is not required, Hologic said.

"Our new Trident specimen radiography system takes advantage of the valuable insights we have gained as the global leader in digital mammography," added Soltani.

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